MAUDE Adverse Event Report: KATENA PRODUCTS, INC. EAGLE VISION 0.6 MILLIMETER PLUG; LACRIMAL STENTS AND INTUBATION SETS

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Product did not work.

• Brand Name: EAGLE VISION 0.6 MILLIMETER PLUG
• Type of Device: LACRIMAL STENTS AND INTUBATION SETS
• Manufacturer (Section D): KATENA PRODUCTS, INC.
• MDR Report Key: 7813295
• MDR Text Key: 118270652
• Report Number: MW5079381
• Device Sequence Number: 0
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1